Florida State University
Tallahassee, Florida, 32306, United States
NCT Number: NCT05571800
This study is designed to explore the effect of mango consumption on glycemic indices, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.
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Notify Me50 year–70 year
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32306, United States
According to the Centers for Disease Control and Prevention (2016), at least 100 million adults in the United States are diagnosed as pre-diabetic or Type 2 diabetic. With the number of cases steadily increasing in this population, healthcare costs have subsequently increased for both the patient and the health care system. To date, there are few studies (limited to animal model and obese Type 2 diabetic humans) that have examined the efficacy of mangoes on health outcomes, particularly related to diabetes. Therefore, the purpose of the current study is to examine the effect of fresh mango on glycemic indices, body composition, and vascular health measures. Upon favorable outcomes, and with more definite evidence from human studies, mangoes can potentially be implemented in America's diet to help mitigate the advancement and diagnoses of pre and Type 2 diabetes and, as a result, aid in a reduction of healthcare costs. The current study is a 24- week, randomized, controlled experiment including 40 overweight or obese, pre-diabetic men and post-menopausal women aged 50 to 70 years with no diagnosed cardiovascular, metabolic, kidney, or other types of chronic disease to be included. Participants will be randomly assigned to one of two groups: 1) one fresh Tommy Atkins mango (120 g) per day or 2) an isocaloric granola bar per day for 24 weeks. Visits will include anthropometric measurements, glucose, and A1C values via finger prick, venous blood samples to analyze biomarkers related to glycemic control and lipid profiles, vascular measures, and body composition. To analyze the effects of the treatment, ANOVA and Bonferroni's test will be utilized. The investigators hypothesize that daily consumption of one mango per day for 24 weeks will improve the indices of glycemic control, cardiovascular health, and body composition in overweight and obese individuals with prediabetes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
120g of fresh Mango
200g isocaloric Granola Bar
Time frame: 3 years
Blood glucose measures evaluated with finger prick and blood glucose meter
Time frame: 3 years
HbA1c evaluated by finger prick and DCA analyzer
Time frame: 3 years
Insulin evaluated by blood draw Enzyme-linked immunosorbent assay
Time frame: 3 years
HOMA-IR evaluated by blood draw 20 ml Enzyme-linked immunosorbent assay
Time frame: 3 years
HOMA-β evaluated by blood draw 20 ml and Enzyme-linked immunosorbent assay
Time frame: 3 years
Systolic and diastolic blood pressure evaluated by automated blood pressure monitor
Time frame: 3 years
Flow-mediated dilation (FMD) evaluated with high-resolution doppler ultrasound (HD11XE, Phillips Ultrasound, Bothwell, WA, USA) with a 3-12 MHz linear array transducer
Time frame: 3 years
Pulse wave velocity (PWV) evaluated with Sphygmocor for pulse wave velocity, aortic blood pressure and augmentation index
Time frame: 3 years
Endothelin-1 (ET-1) evaluated with Enzyme-linked immunosorbent assay
Time frame: 3 years
biomarker of inflammation (C-reactive protein) evaluated by blood draw 20 ml and enzyme-linked immunosorbent assay
Time frame: 3 years
lipid profile evaluated by blood draw and enzyme-linked immunosorbent assay consisting of
Time frame: 3 years
Effect of mango consumption on indicators of cardiovascular health evaluated by lipid profile
Time frame: 3 years
Lean mass evaluated by bioimpedance spectroscopy (BIS)
Time frame: 3 years
fat mass evaluated by bioimpedance spectroscopy (BIS)
Time frame: 3 years
Phase angle (PA) calculated directly from reactance and resistance using the following formula: PA=arctangent reactance(ohm)/resistance (ohm) ×180°/π
Time frame: 3 years
Weight evaluated by Ohaus Portable Electronic CS Series Scales
Time frame: 3 years
evaluated by Gulick fiberglass measuring tape with a tension handle
Time frame: 3 years
hip circumference (HC) evaluated by Gulick fiberglass measuring tape with a tension handle
Time frame: 3 years
waist to hip ratio (WC/HC)
Florida State University
Other
The Effects of Fresh Mango Consumption in Indices of Glycemic Control, Cardiovascular Health, and Body Composition in Normal Weight, Overweight and Obese Individuals with Prediabetes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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